Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MEDTRONIC HALL PROSTHETIC HEART VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC CARDIAC SURGERY 8299 CENTRAL AVE., N.E. SPRING LAKE PARK, MN 55432-3576 |
PMA Number | P790018 |
Supplement Number | S036 |
Date Received | 10/17/2000 |
Decision Date | 11/09/2000 |
Withdrawal Date
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12/23/2011 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ALTERNATE SUPPLIER FOR THE POLYTETRAFLUOROETHYLENE (PTFE) FABRIC CONSTRUCTED OF PTFE YARN. THIS FABRIC IS USED TO MANUFACTURE THE SEWING RING COMPONENT FOR THE MEDTRONIC HALL PROSTHETIC HEART VALVE, MODEL A7700, SIZES 20, 22, AND 24 MM. |
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